TroponinPRO-TROPICSNCT02285686
Prognostic Value of Elevated Troponins in Critical Illness Study: A Pilot Study
An observational study of Troponin and Critical Care, run by McMaster University.
Trial summary
Troponins are sensitive and specific markers of cardiac injury. Critically ill patients frequently have elevated troponins. In this population, distinguishing patients with elevated troponins from those with myocardial infarction is difficult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Troponin, Critical Care, Myocardial Infarction
- How many people
- 251 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to 30 Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients
Who may be able to join
- All adult patients admitted to the participating ICUs of study sites during the study enrollment period will be eligible.
Who cannot join
- Patients who are admitted and die or are discharged within 12 hours
- Patients re-admitted to ICU during the index ICU enrolment month
About this study
Troponins are sensitive and specific markers of cardiac injury. Critically ill patients frequently have elevated troponins. In this population, distinguishing patients with elevated troponins from those with myocardial infarction is difficult. However, troponin elevations on their own seem to be associated with an increased risk of death. The optimal treatment of patients with type 2 myocardial infarction or non ischemia related troponin elevations during critical illness is unclear. There are no trials in the ICU setting to guide management.
This study is a 1-month pilot cohort study of troponin screening in 4 Ontario intensive care units. The objective of this pilot study is to evaluate the ability to perform a larger study, which will determine the prevalence, incidence and risk factors for elevated troponin values, how patients with elevated troponin values are treated as a baseline, and the incidence of myocardial infarction in critically ill patients. Knowing the prognostic impact of these conditions and understanding current management will thereafter guide researchers and clinicians on the importance of carefully evaluating potential risk-modifying therapies.
- Conditions
- Troponin, Critical Care, Myocardial Infarction
- Keywords
- troponin, biomarkers, myocardial infarction, critical illness
- Medical subject headings
- Myocardial Infarction, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Feasibility outcome
Measured: 1 month
Data collection time per patient
Feasibility outcome
Measured: 3 months
rate of successful deferred informed consent definition
Feasibility outcome
Measured: 1 month
Secondary outcomes (3)
All-cause in-hospital mortality
Measured: 3 months
Troponin elevations
Measured: 3 months
Myocardial infarction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion15 Mar 2015
- Study completion30 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TroponinStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285686
- Sponsor's protocol ID
- 14-674
- Other IDs
- 14348
- Acronym
- PRO-TROPICS
- Status last verified
- Oct 2017
- First submitted
- 5 Nov 2014
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Elevated Troponins in Critical Illness Study: A Pilot Study
- ClinicalTrials.gov ID
- NCT02285686
- Acronym / sponsor ID
- PRO-TROPICS / 14-674
- Conditions
- Troponin, Critical Care, Myocardial Infarction
- Keywords
- troponin, biomarkers, myocardial infarction, critical illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 15 Mar 2015 (actual)
- Study completion
- 30 Mar 2015 (actual)
- First posted
- 7 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Troponins are sensitive and specific markers of cardiac injury. Critically ill patients frequently have elevated troponins. In this population, distinguishing patients with elevated troponins from those with myocardial infarction is difficult. However, troponin elevations on their own seem to be associated with an increased risk of death. The optimal treatment of patients with type 2 myocardial infarction or non ischemia related troponin elevations during critical illness is unclear. There are no trials in the ICU setting to guide management.
This study is a 1-month pilot cohort study of troponin screening in 4 Ontario intensive care units. The objective of this pilot study is to evaluate the ability to perform a larger study, which will determine the prevalence, incidence and risk factors for elevated troponin values, how patients with elevated troponin values are treated as a baseline, and the incidence of myocardial infarction in critically ill patients. Knowing the prognostic impact of these conditions and understanding current management will thereafter guide researchers and clinicians on the importance of carefully evaluating potential risk-modifying therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients
Key inclusion criteria (1 listed)
- All adult patients admitted to the participating ICUs of study sites during the study enrollment period will be eligible.
Key exclusion criteria (2 listed)
- Patients who are admitted and die or are discharged within 12 hours
- Patients re-admitted to ICU during the index ICU enrolment month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recruitment rate
Time frame: 1 month
Feasibility outcome
Data collection time per patient
Time frame: 3 months
Feasibility outcome
rate of successful deferred informed consent definition
Time frame: 1 month
Feasibility outcome
3 secondary outcomes
All-cause in-hospital mortality
Time frame: 3 months
Troponin elevations
Time frame: 3 months
Myocardial infarction
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Troponin and Critical Care, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.